510(k) · Cleared
ClearedRemunityPRO+ Pump for Remodulin® (treprostinil) Injection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka R&D Corp · FRN Pump, Infusion
Cleared on Jul 24, 2026 as substantially equivalent to K250357 (Deka Research & Development Corp., 2025) after a 242-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jul 24, 2026
- Review
- 242 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051568 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK051568 Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc. · 2005 · Recalled
- 3 generations backK190182 Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development · 2019
- 2 generations backK241736 Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp. · 2025
- 1 generation backK250357 RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp. · 2025
- This deviceK253703 RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051568 | Cadd-MS 3 Ambulatory Infusion Pump | Smiths Medical MD, Inc. | 2005 | 2 |
| −3 | K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019 | — |
| −2 | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025 | — |
| −1 | K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025 | — |
| 0 (this device) | K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K250357 RemunityPRO™ Pump for Remodulin®…score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionSummary page 5…II Device Panel: General Hospital Predicate Device The predicate device is the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection, K250357, cleared on March 11, 2025. The predicate device has not been subject to a design-related recall. Device Description The Remunit… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (the RemunityPRO+ System) is intended for
continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253703 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253703: RemunityPRO+ Pump for Remodulin® (treprostinil) Injection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253703
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026